Simulation-guided clinical trials: Is EU law ready? – MedCity News

Partner Marco Blei authored an article for MedCity News exploring the role of simulation-guided clinical trials and whether the EU’s regulatory framework is equipped to support their wider adoption.

Marco examines how simulations can help improve clinical trial design, patient safety and efficiency, while highlighting the legal and regulatory considerations surrounding their use. He notes that although EU law does not currently require trial design simulations, a proportionate, risk-based approach could support their adoption, particularly for more complex clinical trials.

The article also considers the intellectual property implications of simulation tools, including the need to balance transparency and reproducibility with the protection of proprietary algorithms, data and know-how.

Read the full MedCity News article >>